FDA.reportPublic FDA data

Anti Allergy

Product NDC
54738-103
11-digit product format
547380103
Labeler code
54738
Product ID
54738-103_5cc3ebfe-ce74-423d-e053-2a91aa0a4616
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-01
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anti Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z
Rxcui1363309

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-103-01Anti Allergy100 in 1 BOTTLETABLET1002
54738-103-03Anti Allergy1000 in 1 BOTTLETABLET10002
54738-103-14Anti Allergy24 in 1 BOTTLETABLET242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-103-01EA - Each54738-1033ba3deb0-2c3a-4c8a-aa9f-4fbfca573a3e12017-11-06
54738-103-03EA - Each54738-10308895da8-8ff1-40c0-8d86-2123a788d39412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-103ANTI ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20171030_316db99f-5a13-48e0-9a6b-ab7a76fe4d28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN316db99f-5a13-48e0-9a6b-ab7a76fe4d282
1363309chlorpheniramine maleate 4 MG Oral TabletSCD316db99f-5a13-48e0-9a6b-ab7a76fe4d282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-103-0154738010301100 TABLET in 1 BOTTLE (54738-103-01) 100 tablet2015-05-010000-00-00NoNoCurrent
54738-103-03547380103031000 TABLET in 1 BOTTLE (54738-103-03) 1000 tablet2015-05-010000-00-00NoNoCurrent
54738-103-145473801031424 TABLET in 1 BOTTLE (54738-103-14) 24 tablet2015-06-010000-00-00NoNoCurrent